A Study of BV-araU in the Treatment of Varicella-Zoster Viral Disease (VZV) in HIV-Infected Children Who Have Not Had Success With or Who Cannot Take Other Treatments for VZV

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To provide oral sorivudine ( BV-araU ) to pediatric HIV-infected patients with varicella-zoster viral disease who have failed or are intolerant of alternative therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Sorivudine

Criteria

Inclusion Criteria

Patients must have:

• HIV infection.

• Cutaneous, visceral, or ocular varicella-zoster viral infection.

• Refractory or intolerant to acyclovir or foscarnet therapy.

• Consent of parent or guardian.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Inability to take oral capsules or tolerate liquids.

Concurrent Medication:

Excluded:

• 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid.

Patients with the following prior condition are excluded:

History of immediate hypersensitivity to nucleoside analogues.

Prior Medication:

Excluded:

• 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid within 4 weeks prior to study entry.

Required:

• Prior acyclovir or foscarnet.